Mobilising Lower Limb Fluid for Hemodynamic Stability in Haemodialysis
Pilot Evaluation of Intermittent Pneumatic Compression and Neuromuscular Electrical Stimulation for Enhancing Vascular Refilling in Haemodialysis
Cardiovascular disease is the leading cause of death of dialysis patients and poor fluid management is associated with the increased risk. One of the principal limitations in avoiding chronic fluid overload in this patient group is the refilling rate the rate at which fluid is transferred from tissues into the vascular system. If this rate cannot match the prescribed rate of fluid removal during dialysis the patient will end up with chronic fluid overload.
Two proposed methods of increasing the rate of refilling are intermittent pneumatic compression (IPC) devices, which increase the pressure of the fluid in tissue, and neuromuscular electrical stimulation (NMES) which activates the muscle pump and lymphatic drainage.
This investigation will trial the use of these two methods in patients suspected of having inadequate refilling rates. Outcome measures will be based on fluid status, presence of oedema and quality of life.
研究概览
地位
条件
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Leeds、英国、LS9 7TF
- 招聘中
- Leeds Teaching Hospitals NHS Trust
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接触：
- David Keane, MSc, CSci
- 电话号码：01132064119
- 邮箱：david.keane@nhs.net
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Presence of lower limb oedema as defined by pitting
- Average post dialysis fluid overload in relation to target weight greater than 0.5 litres
- Greater than one dialysis session that included an intradialytic hypotensive episode in the previous month, defined by saline influsion or nursing intervention
Exclusion Criteria:
- Less than 18 years of age
- Less than 3 months dialysis vintage
- Presence of metal implants, amputations or the inability to be weighed
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：A: baseline - IPC
A: baseline - IPC - washout - NMES - washout - follow up The baseline phase, washout phase and follow up phase will consist of treatment as normal. IPC phase will consist of normal care plus IPC of the lower limbs for the duration of each dialysis session. |
Flowtron, Circulation Booster and Sports XL devices will be used.
Flowtron, Circulation Booster and Sports XL devices will be used.
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其他：B: baseline - NMES
B: baseline - NMES - washout - IPC - washout follow up The baseline phase, washout phase and follow up phase will consist of treatment as normal. NMES phase will consist of normal care plus stimulation of the foot and calf muscles for a period of one hour during dialysis. |
Flowtron, Circulation Booster and Sports XL devices will be used.
Flowtron, Circulation Booster and Sports XL devices will be used.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Fluid Status (Body composition monitor measurement of fluid status)
大体时间：Weekly
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Body composition monitor measurement of fluid statu
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Weekly
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Quality of Life (Validated Kidney Disease Quality of Life (KDQOL36) quality of life measurement questionnaire and patient symptom questionnaire)
大体时间：Weekly
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Validated KDQOL36 quality of life measurement questionnaire and patient symptom questionnaire
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Weekly
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
肾功能衰竭的临床试验
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Camille N. Kotton, MDKamada, Ltd.; University of Texas Southwestern Medical Center招聘中